Amgen Reports Results From Phase III Study Of AMG 416 For Secondary Hyperparathyroidism In Patients With Chronic Kidney Disease

Amgen announced in a press release that its study evaluating AMG 416 for secondary hyperparathyroidism (SHPT) in patients with chronic kidney disease (CKD) receiving hemodialysis has shown positive results. The company’s second Phase III trial met its primary endpoint with 74 percent of patients achieving more than a 30 percent reduction in parathyroid hormone (PTH) levels. In the first Phase III study reported in July 2014, 75.3 percent of patients achieved a reduction in PTH levels.

Sean E. Harper, M.D., EVP of Research and Development at Amgen, said, "The results from this second Phase 3 study help to confirm that AMG 416 could become an important new treatment option for dialysis patients with secondary hyperparathyroidism. We look forward to sharing results of a head-to-head study evaluating AMG 416 compared to cinacalcet next year."

AMG 416

AMG 416, formerly known as velcalcetide, is a peptide agonist of the human cell surface calcium-sensing receptor (CaSR). The novel calcimimetic is administered intravenously. The agent works to bind and activate the calcium-sensing receptor on the parathyroid gland, causing a decrease in PTH. Elevated PTH levels stimulate bone breakdown or soft bones (osteomalacia).

Second AMG 416 Study

In Amgen’s second AMG 416 study, 508 patients participated in a 26-week placebo-controlled trial. The study titled, “Assess the Efficacy and Safety of AMG 416 in the Treatment of Secondary Hyperparathyroidism (SHPT) in Subjects With Chronic Kidney Disease on Hemodialysis,” evaluated safety and efficacy. Participants received an intravenous injection of AMG 416 or a placebo three times a week along with hemodialysis treatment. Doses ranged from 2.5 mg to 15 mg. According to the standard of care, and if prescribed by an individual’s physician, patients received calcium supplements, vitamin D sterols, and phosphate binders. 

Results showed that 74 percent of patients reduced PTH by more than 30 percent from baseline compared to 8.3 percent in the placebo group, meeting the primary endpoint. Secondary endpoints included -7.71 percent change from baseline during the EAP in serum phosphorus (P) concentration in the AMG 416 group compared to  -1.31 percent in the placebo group. In the AMG 416 group, the corrected calcium (cCa) concentration was -7.29 compared to 1.18 percent in the placebo group. Amgen states that all endpoints were statistically significant.